Physical ExerciseNCT03272061
Exercise and Brain Vascular Function
A study testing Aerobic-based exercise program in people with Physical Exercise and Cerebrovascular Function, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Cognitive performance is negatively related to an impaired glucose metabolism, possibly due to impairments in brain vascular function. Supported by the statement from the American Heart and Stroke Association that physical exercise is one of the most effective strategies to protect against cognitive decline, we now… Read more about this study
- Who is it for?
- Ages 60 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Physical Exercise, Cerebrovascular Function, Cerebral Blood Flow
- What is being tested?
- Aerobic-based exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Dec 2017to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged between 60-70 years
- Men
- BMI between 25-35 kg/m2 (overweight and slightly obese)
- Sedentary (not moderately active for 3 times or more per week)
- Fasting plasma glucose < 7.0 mmol/L
- Fasting serum total cholesterol < 8.0 mmol/L
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- Fasting serum triacylglycerol < 4.5 mmol/L
- Systolic blood pressure < 160 mmHg and diastolic blood pressure < 100 mmHg
- Stable body weight (weight gain or loss < 3 kg in the past three months)
- Willingness to give up being a blood donor from 8 weeks before the start of the study, during the study and for 4 weeks after completion of the study
- No difficult venipuncture as evidenced during the screening visit
Who cannot join
- Women
- Current smoker, or smoking cessation < 12 months
- Diabetic patients
- Familial hypercholesterolemia
- Abuse of drugs
- More than 3 alcoholic consumptions per day
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- Use of dietary supplements known to interfere with the main study outcomes as judged by the principal investigators
- Use medication to treat blood pressure, lipid or glucose metabolism
- Use of an investigational product within another biomedical intervention trial within the previous 1-month
- Severe medical conditions that might interfere with the study, such as epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis
- Active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebrovascular accident
- Contra-indications for MRI imaging (e.g. pacemaker, surgical clips/material in body, metal splinter in eye, claustrophobia)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Aerobic-based Exercise on Brain Vascular Function in Elderly Men
Cognitive performance is negatively related to an impaired glucose metabolism, possibly due to impairments in brain vascular function. Supported by the statement from the American Heart and Stroke Association that physical exercise is one of the most effective strategies to protect against cognitive decline, we now hypothesize that exercise-induced changes in glucose metabolism cause beneficial effects on brain vascular function thereby improving cognitive performance. The primary objective of this intervention study is thus to evaluate in sedentary elderly men the effect of a 8-week aerobic-based exercise program on cerebral blood flow, as quantified by the non-invasive gold standard magnetic resonance imaging (MRI) perfusion method Arterial Spin Labeling (ASL). Cerebral blood flow is a robust and sensitive physiological marker of brain vascular function. Secondary objectives are to examine effects on glucose metabolism using the oral glucose tolerance test and cognitive performance as assessed with a neurophysiological test battery.
- Conditions
- Physical Exercise, Cerebrovascular Function, Cerebral Blood Flow, Glucose Metabolism, Cognitive Performance
- Being tested
- Aerobic-based exercise program
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic-based exercise programOther
Aerobic-based exercise will be carried out on a cycling ergometer three times a week for 30 minutes at 70% of the maximal workload. Every two weeks, the maximal workload will be reassessed, and training loads will be readjusted accordingly. Fully supervised training sessions will be performed with three-to-four study participants at a time. Subjects should maintain their body weight during the intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic-based exercise program | Experimental | Not described Receives: Other: Aerobic-based exercise program |
| Control program | No intervention | Maintenance of habitual physical activity levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain vascular function
Cerebral blood flow as quantified non-invasively by the MRI perfusion method Arterial Spin Labeling (ASL)
Measured: Difference between outcomes at the end of an 8-week aerobic-based exercise and control program
Secondary outcomes (2)
Glucose metabolism
Oral Glucose Tolerance Test (OGTT)
Measured: Difference between outcomes at the end of an 8-week aerobic-based exercise and control program
Cognitive performance
Cambridge Neuropsychological Test Automated Battery (CANTAB)
Measured: Difference between outcomes at the end of an 8-week aerobic-based exercise and control program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2017
- Study start1 Dec 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Physical ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will follow in randomized order a tightly controlled, progressive, aerobic-based exercise program or control program for eight weeks, separated by a washout period of twelve weeks.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter J Joris, PhD, Principal investigator, Maastricht University Medical CenterRonald P Mensink, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03272061
- Sponsor's protocol ID
- METC173025
- Status last verified
- Jan 2019
- First submitted
- 29 Aug 2017
- Last updated
- 16 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mashnafi S, Plat J, Mensink RP, Joris PJ, Kleinloog JPD, Baumgartner S. Effects of an 8-week aerobic exercise program on plasma markers for cholesterol absorption and synthesis in older overweight and obese men. Lipids Health Dis. 2021 Sep 21;20(1):112. doi: 10.1186/s12944-021-01537-2.
PubMed 34548089Kleinloog JPD, Mensink RP, Ivanov D, Adam JJ, Uludag K, Joris PJ. Aerobic Exercise Training Improves Cerebral Blood Flow and Executive Function: A Randomized, Controlled Cross-Over Trial in Sedentary Older Men. Front Aging Neurosci. 2019 Dec 4;11:333. doi: 10.3389/fnagi.2019.00333. eCollection 2019.
PubMed 31866855
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Aerobic-based Exercise on Brain Vascular Function in Elderly Men
- ClinicalTrials.gov ID
- NCT03272061
- Acronym / sponsor ID
- METC173025
- Conditions
- Physical Exercise, Cerebrovascular Function, Cerebral Blood Flow, Glucose Metabolism, Cognitive Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 5 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cognitive performance is negatively related to an impaired glucose metabolism, possibly due to impairments in brain vascular function. Supported by the statement from the American Heart and Stroke Association that physical exercise is one of the most effective strategies to protect against cognitive decline, we now hypothesize that exercise-induced changes in glucose metabolism cause beneficial effects on brain vascular function thereby improving cognitive performance. The primary objective of this intervention study is thus to evaluate in sedentary elderly men the effect of a 8-week aerobic-based exercise program on cerebral blood flow, as quantified by the non-invasive gold standard magnetic resonance imaging (MRI) perfusion method Arterial Spin Labeling (ASL). Cerebral blood flow is a robust and sensitive physiological marker of brain vascular function. Secondary objectives are to examine effects on glucose metabolism using the oral glucose tolerance test and cognitive performance as assessed with a neurophysiological test battery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will follow in randomized order a tightly controlled, progressive, aerobic-based exercise program or control program for eight weeks, separated by a washout period of twelve weeks.
| Arm | Type | Receives |
|---|---|---|
| Aerobic-based exercise program | Experimental | Other: Aerobic-based exercise program |
| Control program | No intervention | –Maintenance of habitual physical activity levels |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Aged between 60-70 years
- Men
- BMI between 25-35 kg/m2 (overweight and slightly obese)
- Sedentary (not moderately active for 3 times or more per week)
- Fasting plasma glucose < 7.0 mmol/L
Key exclusion criteria (12 listed)
- Women
- Current smoker, or smoking cessation < 12 months
- Diabetic patients
- Familial hypercholesterolemia
- Abuse of drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic-based exercise programAerobic-based exercise will be carried out on a cycling ergometer three times a week for 30 minutes at 70% of the maximal workload. Every two weeks, the maximal workload will be reassessed, and training loads will be readjusted accordingly. Fully supervised training sessions will be performed with three-to-four study participants at a time. Subjects should maintain their body weight during the intervention period. | Other | Aerobic-based exercise program |
Primary outcome
Brain vascular function
Time frame: Difference between outcomes at the end of an 8-week aerobic-based exercise and control program
Cerebral blood flow as quantified non-invasively by the MRI perfusion method Arterial Spin Labeling (ASL)
2 secondary outcomes
Glucose metabolism
Time frame: Difference between outcomes at the end of an 8-week aerobic-based exercise and control program
Cognitive performance
Time frame: Difference between outcomes at the end of an 8-week aerobic-based exercise and control program
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- Derived from this study: PubMed 34548089Mashnafi S, Plat J, Mensink RP, Joris PJ, Kleinloog JPD, Baumgartner S. Effects of an 8-week aerobic exercise program on plasma markers for cholesterol absorption and synthesis in older overweight and obese men. Lipids Health Dis. 2021 Sep 21;20(1):112. doi: 10.1186/s12944-021-01537-2.
- Derived from this study: PubMed 31866855Kleinloog JPD, Mensink RP, Ivanov D, Adam JJ, Uludag K, Joris PJ. Aerobic Exercise Training Improves Cerebral Blood Flow and Executive Function: A Randomized, Controlled Cross-Over Trial in Sedentary Older Men. Front Aging Neurosci. 2019 Dec 4;11:333. doi: 10.3389/fnagi.2019.00333. eCollection 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter J Joris, PhD principal investigator
Maastricht University Medical Center
Ronald P Mensink, PhD principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic-based exercise program in people with Physical Exercise and Cerebrovascular Function, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain vascular function (time frame: Difference between outcomes at the end of an 8-week aerobic-based exercise and control program). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03272061, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2019; AzTrials last refreshed its copy on 31 Oct 2026.